Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IRBESARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Authors

*S. Hemamrutha, R. Rambabu and S. Vidhyadhara

Description

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of Irbesartan (IRB) and Hydrochlorothiazide (HCTZ) in combination. A&nbsp; C 18 (Agilent ODS UG 5 Column 250mmX4.5 mm Dimensions) column with mobile phase composition&nbsp; Methanol: Acetonitrile: Buffer (10mM potassium dihydrogen phosphate pH6.8)(40:30:30%v/v/v) was used at isocratic mode and eluents were monitored at 264 nm. The retention times of IRB and HCTZ were 5.1 and 3.1min respectively. Irbesartan showed good linearity in the concentration range of 24-120 &micro;g/ml with a correlation coefficient (R) of 0.9993 and 2-10 &micro;g/ml for Hydrochlorothiazide with correlation coefficient (R) 0.9995 respectively.&nbsp; The proposed method was validated as per ICH guidelines and method showed good precision with percent relative standard deviation less than 2%. The assay values of Irbesartan and Hydrochlorothiazide were found to be 99.85 and 101% respectively and recovery values are within the limits of 98-102% indicating the proposed method was accurate and precise for the simultaneous estimation of Irbesartan and Hydrochlorthiazide in bulk and pharmaceutical dosage forms.